FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HANDI OXYGEN ANALYZER
K Number: K973282
·
Decision Mar 4, 1998
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
120
Applicant Total
4
Review Days
183
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Basic Information
- Device Name
- HANDI OXYGEN ANALYZER
- K Number
- K973282
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1720
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ceramatec, Inc.
- Date Received
- September 2, 1997
- Decision Date
- March 4, 1998
- Product Code
- CCL
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | FDA class 2 | Anesthesiology |
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